Efficacy of Neonatal Release of Ankyloglossia

United States Naval Medical Center, Portsmouth

Status: Completed

Conditions: Ankyloglossia

Treatments: Other: Sham procedure; Procedure: Frentomy

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00967915

2007.0077

Details and patient eligibility

About

The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

Full description

The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Enrollment: 58 patients

Sex: All

Ages: Under 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
• Report of maternal nipple pain with feeding
• Report of difficulty with infant breast feeding

Exclusion criteria

• Significant craniofacial defects
• Age >14 days at enrollment
• Any maternal contraindication to breastfeeding
• Neurologic defects that would impair breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Frenotomy

Experimental group

Description:

Group of neonates that will receive frenotomy for tongue-tie

Treatment:

Procedure: Frentomy

No frenotomy

Sham Comparator group

Description:

Group of infants that will undergo sham procedure (no frenotomy performed)

Treatment:

Other: Sham procedure